Atrial Fibrillation (Prevention of Stroke)ADHPNCT07684053
Digital Screening for Atrial Fibrillation to Prevent Stroke
A study testing Smartphone-based digital atrial fibrillation screening and management pathway in people with Atrial Fibrillation (Prevention of Stroke) and Stroke, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The Austrian Digital Heart Study is a population-based, siteless, randomized, controlled digital trial testing whether a smartphone-based atrial fibrillation screening and management pathway reduces stroke hospitalizations compared with usual care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation (Prevention of Stroke), Stroke
- What is being tested?
- Smartphone-based digital atrial fibrillation screening and management pathway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,060 participants
- Where
- 1 siteAustria
- Study dates
- 29 Jun 2026to 1 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Policyholder in Austria (active unique social insurance number)
- Written electronic informed consent Exclusion Criteria
- Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Schreinlechner, MD contact
Austria1 site, 1 recruiting
- Recruiting
Department of Internal Medicine III, Medical University Innsbruck
Innsbruck, Tyrol, 6020
Michael Schreinlechner, MD, +4351250425621, michael.schreinlechner@i-med.ac.at
Sebastian J Reinstadler, MD, PhD, Sebastian-Johannes.Reinstadler@i-med.ac.at
About this study
Official title: Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study
The Austrian Digital Heart Study is a population-based, siteless, randomized, controlled digital trial testing whether a smartphone-based atrial fibrillation screening and management pathway reduces stroke hospitalizations compared with usual care. Adults aged 65 years or older in Austria are randomized to either a digital intervention using the 'Pulskontrolle' app or to usual care. The intervention includes smartphone-camera photoplethysmography for atrial fibrillation screening, confirmatory 7-day ECG patch monitoring in case of suspected atrial fibrillation, and digital education and management support. The primary outcome is hospitalization for stroke of any type within 48 months.
Read the detailed description
Atrial fibrillation is common in older adults, often remains undetected, and is a major risk factor for stroke, heart failure, hospitalization, and death. Digital screening using smartphone-based photoplethysmography provides substantial benefits in detecting atrial fibrillation compared to usual care, but it remains unclear whether such screening improves clinical outcomes.
The Austrian Digital Heart Study tests a brand-independent digital atrial fibrillation screening and management pathway embedded in the Austrian public health-care system. Participants randomized to the intervention arm use the 'Pulskontrolle' smartphone application for repeated photoplethysmographic pulse-wave (PPG) recordings. If atrial fibrillation is suspected, confirmatory 7-day ECG patch monitoring is initiated. Participants with positive PPG receive structured digital information, telehealth support, and guideline-oriented management recommendations.
The control arm receives usual care without active app-based atrial fibrillation screening. The primary endpoint is hospitalization for stroke of any type within 48 months after randomization. Secondary outcomes include mortality, cardiovascular morbidity, bleeding, atrial fibrillation-related outcomes, health-care utilization, and health-economic endpoints.
- Conditions
- Atrial Fibrillation (Prevention of Stroke), Stroke
- Being tested
- Smartphone-based digital atrial fibrillation screening and management pathway
- Keywords
- Digital Health, Atrial Fibrillation Screening, Photoplethysmography, Smartphone, ECG Patch, Stroke Prevention, Randomized Controlled Trial, Siteless Trial, Telehealth
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based digital atrial fibrillation screening and management pathwayDevice
Participants randomized to the digital intervention arm receive access to a smartphone-based atrial fibrillation screening and management pathway. The intervention includes photoplethysmography-based pulse wave measurements using a CE-certified smartphone application, followed by confirmatory 7-day ECG patch monitoring in participants with abnormal findings suggestive of atrial fibrillation. Participants with suspected or confirmed atrial fibrillation receive structured digital information, adherence support, and the option of telehealth guidance to facilitate guideline-oriented care. Treatment decisions remain the responsibility of the participant's usual treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Digital atrial fibrillation screening and management | Experimental | Participants assigned to the experimental arm are offered access to the 'Pulskontrolle' app. The app supports smartphone-camera photoplethysmography recordings for atrial fibrillation screening, digital education, and atrial fibrillation management support. Participants with suspected atrial fibrillation undergo confirmatory 7-day ECG patch monitoring. Confirmed atrial fibrillation triggers structured digital and telehealth-supported guidance according to guideline-oriented care pathways. Receives: Device: Smartphone-based digital atrial fibrillation screening and management pathway |
| Usual care | No intervention | Participants assigned to the control arm receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for stroke of any type (ischemic or hemorrhagic)
Measured: Up to 48 months
Secondary outcomes (9)
Hospitalization for Ischemic stroke
Measured: Up to 48 months
Hospitalization for Hemorrhagic stroke
Measured: Up to 48 months
All-cause mortality
Measured: Up to 48 months
Cardiovascular mortality
Measured: Up to 48 months
Hospitalization for heart failure
Measured: Up to 48 months
The combination of hospitalization for stroke, hospitalization for heart failure and cardiovascular death.
Measured: Up to 48 months
Hospitalization for bleeding
Measured: up to 48 months
Fatal bleeding
Measured: up to 48 months
Cost and incremental cost effectiveness ratio
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start29 Jun 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion1 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (Prevention of Stroke)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100,060 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- AIT Austrian Institute of Technology GmbH, Medical University of Graz, UMIT Tirol
- Responsible party
- Sponsor
- Investigators
- Axel Bauer, Study chair, Medical University InnsbruckSebastian J Reinstadler, MD, PhD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684053
- Sponsor's protocol ID
- 1408/2025
- Acronym
- ADHP
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Screening for Atrial Fibrillation to Prevent Stroke: The Randomized Austrian Digital Heart Study
- ClinicalTrials.gov ID
- NCT07684053
- Acronym / sponsor ID
- ADHP / 1408/2025
- Conditions
- Atrial Fibrillation (Prevention of Stroke), Stroke
- Keywords
- Digital Health, Atrial Fibrillation Screening, Photoplethysmography, Smartphone, ECG Patch, Stroke Prevention, Randomized Controlled Trial, Siteless Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100,060 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- AIT Austrian Institute of Technology GmbH, Medical University of Graz, UMIT Tirol
- Study start
- 29 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 1 Jun 2032 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Austrian Digital Heart Study is a population-based, siteless, randomized, controlled digital trial testing whether a smartphone-based atrial fibrillation screening and management pathway reduces stroke hospitalizations compared with usual care. Adults aged 65 years or older in Austria are randomized to either a digital intervention using the 'Pulskontrolle' app or to usual care. The intervention includes smartphone-camera photoplethysmography for atrial fibrillation screening, confirmatory 7-day ECG patch monitoring in case of suspected atrial fibrillation, and digital education and management support. The primary outcome is hospitalization for stroke of any type within 48 months.
Detailed description
Atrial fibrillation is common in older adults, often remains undetected, and is a major risk factor for stroke, heart failure, hospitalization, and death. Digital screening using smartphone-based photoplethysmography provides substantial benefits in detecting atrial fibrillation compared to usual care, but it remains unclear whether such screening improves clinical outcomes.
The Austrian Digital Heart Study tests a brand-independent digital atrial fibrillation screening and management pathway embedded in the Austrian public health-care system. Participants randomized to the intervention arm use the 'Pulskontrolle' smartphone application for repeated photoplethysmographic pulse-wave (PPG) recordings. If atrial fibrillation is suspected, confirmatory 7-day ECG patch monitoring is initiated. Participants with positive PPG receive structured digital information, telehealth support, and guideline-oriented management recommendations.
The control arm receives usual care without active app-based atrial fibrillation screening. The primary endpoint is hospitalization for stroke of any type within 48 months after randomization. Secondary outcomes include mortality, cardiovascular morbidity, bleeding, atrial fibrillation-related outcomes, health-care utilization, and health-economic endpoints.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital atrial fibrillation screening and management | Experimental | Device: Smartphone-based digital atrial fibrillation screening and management pathwayParticipants assigned to the experimental arm are offered access to the 'Pulskontrolle' app. The app supports smartphone-camera photoplethysmography recordings for atrial fibrillation screening, digital education, and atrial fibrillation management support. Participants with suspected atrial fibrillation undergo confirmatory 7-day ECG patch monitoring. Confirmed atrial fibrillation triggers structured digital and telehealth-supported guidance according to guideline-oriented care pathways. |
| Usual care | No intervention | –Participants assigned to the control arm receive usual care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- Policyholder in Austria (active unique social insurance number)
- Written electronic informed consent Exclusion Criteria
- Currently treated with oral anticoagulation b) Cardiac implanted electronic device (CIED)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-based digital atrial fibrillation screening and management pathwayParticipants randomized to the digital intervention arm receive access to a smartphone-based atrial fibrillation screening and management pathway. The intervention includes photoplethysmography-based pulse wave measurements using a CE-certified smartphone application, followed by confirmatory 7-day ECG patch monitoring in participants with abnormal findings suggestive of atrial fibrillation. Participants with suspected or confirmed atrial fibrillation receive structured digital information, adherence support, and the option of telehealth guidance to facilitate guideline-oriented care. Treatment decisions remain the responsibility of the participant's usual treating physician. | Device | Digital atrial fibrillation screening and management |
Primary outcome
Hospitalization for stroke of any type (ischemic or hemorrhagic)
Time frame: Up to 48 months
9 secondary outcomes
Hospitalization for Ischemic stroke
Time frame: Up to 48 months
Hospitalization for Hemorrhagic stroke
Time frame: Up to 48 months
All-cause mortality
Time frame: Up to 48 months
Cardiovascular mortality
Time frame: Up to 48 months
Hospitalization for heart failure
Time frame: Up to 48 months
The combination of hospitalization for stroke, hospitalization for heart failure and cardiovascular death.
Time frame: Up to 48 months
Hospitalization for bleeding
Time frame: up to 48 months
Fatal bleeding
Time frame: up to 48 months
Cost and incremental cost effectiveness ratio
Time frame: Up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Schreinlechner, MD contact
Axel Bauer study chair
Medical University Innsbruck
Sebastian J Reinstadler, MD, PhD principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based digital atrial fibrillation screening and management pathway in people with Atrial Fibrillation (Prevention of Stroke) and Stroke, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian J Reinstadler, MD, PhD (+4351250425621, sebastian-johannes.reinstadler@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization for stroke of any type (ischemic or hemorrhagic) (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.